A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

Phase 1RecruitingNCT05362773

MacroGenics130 enrolled

Overview

CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024. Participants will receive treatment with MGD024 in consecutive 28-day cycles for a study treatment period of up to 12 cycles (approximately 1 year) or until treatment or study discontinuation criteria are met. Response assessments will be performed after Cycle 1 and then after every even numbered cycle starting with Cycle 2 until progression or study treatment discontinuation. Participants will be checked for side effects throughout the study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Leukemia, Acute Myeloid Myelodysplastic Syndromes Classical Hodgkin Lymphoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures. * Participants with * primary or secondary acute myeloid leukemia (AML) except acute promyelocytic leukemia, * primary or secondary myelodysplastic syndrome (MDS) with prognostic score of \>3 and \<20% bone marrow blasts, * classical Hodgkin lymphoma (cHL), * chronic myelogenous leukemia (CML), * b-cell acute lymphocytic leukemia (B-ALL), * hariy cell leukemia (HCL), * advanced systemic mastocytosis (ASM), or * blastic plasmacytoid dendritic cell neoplasm (BPDCM) * Relapsed after or refractory to at least one prior line of therapy and with no available potentially curative treatment option. * Evidence of at least 20% of malignant cells with CD123 expression. * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. * Life expectancy of at least 12 weeks. * Acceptable laboratory values, and heart function. * Continuing side effects of prior treatment are mild * Women and men of childbearing potential must agree to use highly effective forms of contraception throughout the study through 4 months after the last dose of MGD024. Exclusion Criteria: * Prior treatment with an anti-CD123-directed agent (except patients with BPDCN, who are allowed to have received prior tagraxofusp). * Known involvement of central nervous system (CNS) by the disease under investigation. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient. * Systemic anti-cancer therapy, investigational therapy, corticosteroids or other immune suppressive drugs within 14 days of first dose * Vaccination with any live virus vaccine within 4 weeks prior to first dose. Inactivated annual influenza and SARS-CoV-2 vaccination are allowed.

Locations (7)

Colorado Blood Cancer Network

Denver, Colorado, United States

RECRUITING

University of Maryland, Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

RECRUITING

START - Midwest

Grand Rapids, Michigan, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

COMPLETED

South Austin Medical Center

Austin, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Number of severe side effects in patients receiving MGD024

Observation of side effects determines the highest safe dose for further study

Time frame: First 28 days of the study

Number and types of adverse events (AEs), including serious adverse events (SAEs), and AEs leading to treatment discontinuation.

Observation of side effects determines the highest safe dose for further study

Time frame: Throughout study participation, up to 12 months.

Secondary Outcomes

Mean maximum concentration

The highest concentration of MGD024 at the end of the infusion

Time frame: Throughout study participation, up to 12 months.

Mean area under the concentration-time curve (AUC)

Total body exposure to MGD024

Time frame: Throughout study participation, up to 12 months.

Number of participants with anti-drug antibody formation

Number of patients who develop antibodies against MDG024

Time frame: Throughout study participation, up to 12 months.

Overall response rate

The proportion of patients with a complete response or a partial response to treatment

Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.

Complete response rate

The proportion of patient achieving a complete response according to disease-specific criteria

Time frame: Disease response assessment on Day 28, Day 56, then every 56 days throughout the study, up to 12 months.

Median progression free survival

The time between the first dose date to the date of first documented disease-specific progression or death from any cause

Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.Assessed from Day 1 throughout the study until individual participant discontinuation, up to 12 months. Survival from Day 1 throughout the study.

Median time to response

The time between the first dose and the date of complete or partial response.

Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.

Median duration of response

The time between the date of initial response to the date of disease-specific progression or death from any cause

Time frame: Disease response is assessed approximately every 56 days throughout the study, up to 12 months.

Overall survival

The time between the first dose date to the date of death from any cause

Time frame: Assessed from Day 1 throughout the study until individual participant study discontinuation, up to 12 months.

Number of participants with AEs and SAEs occurring after administration of tocilizumab or etanercept for cytokine release syndrome (CRS)

Time frame: Throughout study participation, up to 12 months.

Number of participants with changes in cytokines or C-reactive protein after administration of tocilizumab or etanercept

Time frame: Throughout study participation, up to 12 months.

Outcome of CRS event in participants treated with tocilizumab or etanercept

Time frame: Throughout study participation, up to 12 months.

A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts